Diaphragm pump protection device for a breastpump

ABSTRACT

A prophylactic device for protecting the diaphragm of a pump, such as a diaphragm pump for a breastpump, from fluid (air/milk) is disclosed. A removably mounted flexible cover is located between the shell of the pump and the movable diaphragm membrane within the shell which isolates the membrane from fluid. The cover is removable for at least one of cleaning and disposal. The flexible membrane has a circumferential rim upon which the cover is received over the rim. The shell has an internal opening defined therein sized to encompass the rim with the cover mounted on the rim in a substantially airtight fit. The cover thereby forms a gasket between the rim and shell.

This application is a continuation-in-part of U.S. patent applicationSer. No. 09/055,101, filed Apr. 3, 1998 now U.S. Pat. No. 6,257,847,which is a continuation-in-part of U.S. application Ser. No. 08/510,714,now U.S. Pat. No. 5,776,098.

This application claims the benefit of Provisional Application No.60/170,079 filed Dec. 10, 1999.

FIELD OF THE INVENTION

This invention relates to breastpumps for drawing breastmilk, andparticularly to a motorized, such as electrically driven, breastpump.

BACKGROUND OF THE INVENTION

Breastpumps for use by nursing mothers are well known. They allow thenursing woman to express the breastmilk as necessary or convenient, andfurther provide collection of the breastmilk for later use. For somemothers, breastpumps may be a necessity, such as when the child hassuckling problems, or if the mother has problems with excessive ordeficient milk production, or soreness, deformation or injury of themammilla.

Manual breastpumps are commonplace, primarily because they arerelatively inexpensive and easy to transport. Being manually driven,however, stroke rate and suction pressure produced can be uneven, andoperating the pump can ultimately be tiring.

Electrically-driven breastpumps are also commonplace. They may be of asubstantially large size of a non-portable or semi-portable type,typically including a vacuum pump which has an electric motor that plugsinto standard house current. Advantages of this type of pump are readycontrollability and regulation of the vacuum, and the ability to pumpboth breasts at once. That is, the nursing woman has both hands free tohold two breastpump shields in place for pumping of both breasts at thesame time.

Battery-driven breastpumps have also been developed. These breastpumpshave the advantages of controllability and regulation of the vacuum, aswell as being easily carried. Such a battery-driven portable breastpumpis described in U.S. Pat. No. 4,964,851, for example. This breastpump,sold under the name MINIELECTRIC by Medela, Inc., is lightweight andachieves good vacuum (i.e., negative pressure) regulation in preferredlimits, for example, between about 100 and about 220 mmHg. The LACTINAbreastpump sold by Medela, Inc. is also another type of breast pumpwhich may be driven by battery as well as house current. It is generallydisclosed in U.S. Pat. No. 5,007,899.

Electrically driven motorized breastpumps have almost universally beendeveloped with a single type of “cycle” for a given pump. That is, thedriving mechanism for generating the vacuum (negative pressure) to beapplied at the breast in the more sophisticated pumps is geared to aparticular sequence, or curve, of negative pressure increase (i.e.,increasing suction), and then release. This is often aimed atreproducing in some sense the suckling action of an infant, forinstance. Breastpumping can cover a range of different conditions,however, such as where the mother's nipples are sore for some reason,there is a state of significant engorgement, some nipple stimulation maybe particularly desired, let-down and relaxation may be of particularinterest, it may be desired to increase milk production, and so on.

Some breastpumps provide the user with the ability to vary the amount ofvacuum being applied, as well as the speed of the pumping action (i.e.,number of cycles per minute). In some instances in the prior art, speedand vacuum level may influence each other, such that as speed increasesso does the vacuum level. The basic “curve” remains fixed, however, andthe user must adapt as best she can to making variations within thatparticular curve built into the machine, which typically has beengeneralized for the overall population of users.

SUMMARY OF THE INVENTION

It is a principal objective of the present invention to provide abreastpump which can be programmed to generate, among other things, aplurality of differing milk expression (extraction) sequences, orcurves. To this end, the invention in one form is a breastpumpcomprising a breastshield having a portion within which a woman's breastis received for the expression of milk. A source of vacuum is incommunication with the breastshield. There is a mechanism for operatingthe source of vacuum according to a first sequence, and a controller foroperating the source of vacuum according to a second sequence.

The controller can have a preset program for the second sequence whichis a milk letdown sequence, for example. Preferably, the breastpump hasa plurality of different programs for the controller wherein eachprogram has a different sequence.

In one embodiment of the invention, a motorized pump (e.g., compressedair, battery and/or house current) is provided with amicroprocessor-based controller. Cards, with memory “chips,” containingdifferent suction curves adapted for varying conditions and objectivesare included for programming the controller in this embodiment. A userselects a desired program, and that card is then read by a mechanismproviding input to the controller. It should be noted that while suctioncurves are generally addressed in the first instance herein, the milkexpression sequences may also include a positive pressure aspect. Theprogramming could also be provided via other media, including discs,CDs, infrared data transfer, electronic feed (e.g., an Internetconnection), and so forth.

A significant, and heretofore unavailable advantage realized by thepresent invention is the ready ability to modify the breastpump suctionaction to a variety of desired conditions, and provide this ability tothe end-user. An attendant advantage is that, as the science ofbreastpumping continues to make advances, new and improved suctioncurves and sequences can be made available on further cards, or otherprogram-inputting means.

Yet another attendant advantage is that the programmable pump can alsorecord data relating to its use and operation. That data could bestored, for instance, and then retrieved as by downloading through anInternet connection, magnetic recording (disk or card), and the like.This data retrieval would be useful in medical research, for updatingthe pump with new data, for monitoring usage, just for some instances.

Further, a program could be made of a particular infant's sucklingpattern. That program could then be used to operate the pump, and thenvaried over time as the infant grows.

In yet another aspect of the invention, an improved breastpump isprovided which has a pre-programmed milk let-down sequence. The let-downsequence is most advantageously made available through a button or thelike provided on the breastpump used to actuate the sequence.

In still another aspect of the invention, a breastpump includes anelectric motor having a reduction gear system with at least first andsecond belts conveying motive power to a movable member of an expansiblechamber device wherein a vacuum is generated. The expansible chamberdevice is, in one embodiment, a pair of diaphragm pumps. Each diaphragmpump has a membrane which is movable relative to a shell, each saidmembrane being connected to a respective drive shaft, each shaft beingmounted to a respective belt for linear movement with the respectivebelt.

The present invention in another significant aspect has as an objectiveto provide a breastpump with one or more novel suction sequences whichare considered to produce advantageous particularized results. Suchsequences include, but are not limited to: a suction method (e.g.,program or curve) for a sore nipple condition; a suction method forincreased milk production; an improved suction method in general; and amethod for nipple stimulation.

A method for operating a breastpump for a sore nipple conditionaccording to the present invention comprises varying the amount ofvacuum within a range of from about 20 mmHg (the least vacuum) to about250 mmHg (the greatest vacuum) while simultaneously varying the overallsuction cycle from about 25 cycles/min. at the least vacuum to about 40cycles/min. at the greatest vacuum, such that for a lower vacuum appliedthere is an increase in the number of cycles. In general, this programis intended to provide a lower peak vacuum over a longer cycle.

A method for operating a breastpump which is considered to yield anincrease in milk output according to the present invention comprisesoperating the pump at a rapid cyclical rate on the order of about 120cycles/min., with a negative pressure in the range of about 50 to about150 mmHg. This method further preferably includes a pause after eachperiod of vacuum application, such as applying the vacuum for about tenseconds of vacuum, with then a two second pause.

A method for operating a breastpump according to yet another aspect ofthe invention comprises varying the vacuum within a range of about 100(the least vacuum) to about 250 mmHg (the greatest vacuum), whilesimultaneously varying the overall suction cycle from about 47cycles/min. at the greatest vacuum to about 78 cycles/min. at the leastvacuum, such that for a lower vacuum applied there is an increase in thenumber of cycles, with a cycle following a curve which initially buildsto a peak negative pressure, then smoothly starts a pressure increase(less negative) along an initial slope but then slows the pressureincrease briefly, before continuing on essentially said initial slopefor the negative pressure release.

A still further aspect of the present invention is a unique breastpumpassembly having features including: a compact housing design andbreastshield carrying casing; and a double-diaphragm pumping mechanism.

A prophylactic device for protecting the diaphragm from fluid (air/milk)is additionally provided. In one embodiment of this aspect of theinvention, a diaphragm pump for a breastpump comprises a shell having agenerally hemispherical interior shape with a flexible membrane movablewithin the hemispherical shape to expand and contract a volume createdin a chamber defined between the membrane and the shell. A mechanismconnected to the membrane, such as a puller, moves the membrane toexpand and contract the volume. A port is provided in the shell throughwhich air moves in response to expansion and contraction of the volume,such that vacuum can be communicated to a breastshield throughconnection to the port.

A removably mounted flexible cover is located between the shell and themembrane which isolates the membrane from fluid. The cover is removablefor at to least one of cleaning and disposal. To that end, the flexiblemembrane has a circumferential rim upon which the cover is received overthe rim. The shell has an internal opening defined therein sized toencompass the rim with the cover mounted on the rim in a substantiallyairtight fit. The cover thereby forms a gasket between the rim andshell. A one-way valve extending through the membrane is additionallyprovided, allowing exhaustion of air between the membrane and cover.

Yet another significant aspect of the present invention is considered tobe a manually operated control, such as a rotary knob, which is used tosimultaneously adjust the suction level as well as rate within asequence. In this aspect of the invention, the suction “force” and“speed” are tied together in an inverse relationship. As the suctionforce (vacuum) is increased, for example, the rate (cycle) is decreased;as the vacuum is decreased, the cycle increases.

These and other features and advantages of the present invention will befurther understood and appreciated when considered in relation to thefollowing detailed description of embodiments of the invention, taken inconjunction with the drawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front perspective view of a breastpump assembly made inaccordance with aspects of the present invention;

FIG. 2 is a side elevational view of the breastpump of FIG. 1;

FIG. 3 is a rear perspective view of the breastpump of FIG. 1;

FIG. 4 is a perspective view of the breastpump of FIG. 1 looking at thebottom;

FIG. 5 is a top view of the breastpump of FIG. 1 with a cover removedrevealing diaphragm pumps;

FIG. 6 is an enlarged side view of the breastpump of FIG. 1 adjacent thebottom highlighting the program card insert slot;

FIG. 7 is a bottom perspective view of the breastpump of FIG. 1 showingbattery arrangement;

FIG. 8 is a somewhat exploded assembly view of the major components ofthe breastpump of FIGS. 1 through 5, with a modified top cover for thediaphragm pump assembly;

FIG. 9 is a diagrammatic representation of the interaction of variouscomponents with the controller;

FIG. 10 is a schematic-type representation of a data storage andretrieval process that can be effected in accordance with the presentinvention;

FIGS. 11 through 14 are various methods (curves) for operating thebreastpump to differing ends;

FIG. 15 is a front perspective view of another embodiment of abreastpump assembly made in accordance with aspects of the invention;

FIG. 16 is a rear perspective view of the FIG. 15 embodiment;

FIG. 17 is a somewhat exploded assembly view of the major components ofyet another breastpump made in accordance with the present invention;

FIG. 18 is an enlarged front perspective view of the motor drive of thebreastpump of FIG. 17;

FIG. 19 is a view similar to that of FIG. 18 but from a top perspective;

FIG. 20 is an enlarged assembly view of the diaphragm pump mechanism;

FIG. 21(a) is a cross-sectional view of the assembled diaphragm pump ofFIG. 20;

FIG. 21(b) is an elevational view of the assembled diaphragm pump ofFIG. 20;

FIG. 21(c) is a top view of the assembled diaphragm pump of FIG. 20;

FIG. 22 is a sectional view of the assembled breastpump of FIG. 17 takenthrough the middle of the breastpump along its long lateral axis (sideto side) looking rearwardly;

FIG. 23 is a sectional view similar to that of FIG. 22 taken along aplane forwardly of that of FIG. 22; and

FIG. 24 is a sectional view similar to that of FIG. 22 taken along aplane behind the electric motor looking back to front.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION The BreastpumpAssembly

Referring to FIGS. 1 through 7 initially, a breastpump assembly of thepresent invention in one form has an aesthetically pleasing and compactdesign. The housing for the major components of the assembly is a casing10 made of a rigid high impact plastic. As shown, it has a generallyellipsoidal cross-section along its vertical axis, yielding a pleasingsmooth curving look to the casing exterior. The casing 10 is closed atits upper end by an upper housing part 11, to which is affixed acarrying handle 12.

In this first embodiment, carrying handle 12 has a pair of cradles 15formed in opposite ends thereof. These cradles 15 are adapted to receiveand support the funnel portions 16 of respective breastshields 17. Thesebreastshields 17 (sometimes referred to themselves as breastpumps) areof the type shown and described in U.S. Pat. Nos. 4,964,851 and4,929,229, for instance. Further detail regarding the breastshields 17may be obtained through reference to those patents, but will be omittedherein since the inventive features in point in this application are notcontingent upon the breastshield being used, so long as it is suitableto the task of milk expression.

In general, however, the breastshields 17 have the aforementioned funnelportion 16 which communicates with conduit structure connecting to acontainer (bottle) 18. This particular breastshield 17 is adapted forboth manual as well as motorized pumping. It has a collar 20 to which amanually-driven piston pump (not shown) is screw-threaded for attachmentand use in one mode of operation. When an electrically operated vacuumpump is to be employed, there is a port provided inside of the collar 20which is in communication with the funnel portion, and to which a tubefrom the vacuum pump is releasably connected to convey vacuum to thebreastshield. Again, such detail is well known, and can be gleaned fromthe foregoing patents, among other public sources. In operation ineither mode, the widened (conical) portion of the breastshield 17 isplaced on the breast for drawing vacuum within the shield, and therebydrawing milk through a pulling force applied to the breast. Milk drawnfrom the breast is collected in the bottle 18.

FIGS. 15 and 16 show a modified exterior for the breastpump 10′ (primenumbers being used herein to refer to similar but modified parts). Inthis version the breastshields 17 are not cradled by the handle 12′, butinstead are carried in a holder 26 mounted to the back of the unit.

The Drive Motor

Referring to FIG. 8 initially, casing 10 has a drive unit 25 mountedtherein. There are, of course, any number of drives that may be used fordiaphragm pumps such as those used in the instant embodiment. Indeed,the type of pump (diaphragm, piston, etc.) is not necessarilysignificant to certain aspects of the present invention. The drivingmechanism for the breastpump shown for the embodiment in point, however,is a linear drive for the diaphragm pumps consisting of a reductiondrive arrangement and a 12 V DC-motor 28.

It will be noted that the FIG. 8 embodiment is substantially the same asthat of FIGS. 1 through 7, except for a modified cover for the upperhousing, which here includes the rigid shells 24 for the diaphragms 34as part of the cover 35. The diaphragm pumps 30 will be furtherdescribed hereafter.

FIG. 17 shows yet another version of a breastpump of the presentinvention substantially the same as that of FIGS. 1 through 8, exceptwith a modified cover 35″ and shell 24″ for the diaphragm pump 30. Thebreastshield holder of the FIGS. 15 and 16 embodiment has also beenslightly modified. It is with respect to this FIG. 17 embodiment thatthe majority of the interior detail of the breastpump will be furtherunderstood.

Turning now to FIGS. 18, 19 and 22 through 24 in particular, thereduction gearing contains belts 27 a, 27 b and 27 c. Power istransferred from the shaft 29 of motor 28 to belt 27 a. Belt 27 a isreceived in a channel of wheel 51, which is mounted to the drive chassis62 on rotatable shaft 52. Shaft 52 is fixed to rotate with wheel 51. Afreewheel 53 is mounted on a shaft 54 fixed to the chassis 62 to freelyrotate, and engages the outside of belt 27 a, producing more surfaceengagement by the belt 27 a with wheel 51.

Shaft 52 has a small toothed gear 55 mounted thereon. Belt 27 b istoothed, and engages the gear 55. Toothed belt 27 b furthermore engagesa larger toothed gear 56 fixed to rotating shaft 57 (FIGS. 22 and 24).Part of gear 56 is small toothed gear portion 58. Belt 27 c, which isalso toothed, engages gear 58 as well as toothed gear 59. Gear 59 isfixedly mounted to rotating shaft 70. Fixed at each end of shaft 70 aresmall toothed gears 71 a, 71 b. Toothed belts 72 a, 72 b respectivelyengage gears 71 a, 71 b and freely rotating toothed gears 73 a, 73 b.

Diaphragm pusher (push/pull) shafts 74 a, 74 b are respectively clampedto belts 72 a, 72 b at one end. The other end engages the interior of arespective diaphragm membrane member 34 (FIG. 22, and also see FIGS. 20and 21(a)). Here, a screw engagement with the shafts 74 a, 74 b wasused, with a threaded nut-like element 37 mounted in a reinforcedcentral area of membrane 36 (again, the diaphragm pumps 30 are describedin more detail below). Both of the pusher shafts 74 a, 74 b move intandem as driven by respective belts 72 a, 72 b.

Accordingly, as motor drive shaft 29 turns, belt 27 a rotates shaft 52via wheel 51. Belt 27 b is in turn thereby driven off of smaller gear55, causing rotation of shaft 57, which in turn rotates larger gear 56and its smaller part 58, to thereby turn shaft 70 via belt 27 c whichcouples gear part 58 with larger gear 59. This transfers the motion viagears 71 a, 71 b to belts 72 a, 72 b, imparting a linear movement to thepusher shafts 74 a, 74 b. A forward and then backward stroke isgenerated, through reversal of the motor shaft 29 direction. Reductiongearing is thus obtained as desired through appropriate selection of thevarious gears/wheels noted above.

The location of the shafts 74 a, 74 b along the path of travel, as wellas the length of the stroke, is measured by position sensing mechanism78, which can be of any standard and well known variety. This sensingmechanism 78 uses a toothed wheel 78 a mounted to the shaft 29 of motor28, which is registered by counter 78 b. Signals generated by thecounter 78 b are processed by the cpu of the breastpump.

A negative pressure, or vacuum, is generated in a pair of diaphragmpumps 30. Each diaphragm pump has a flexible membrane 34 mounted in theupper housing 11 assembled with a respective rigid shell 24 (and seeFIGS. 20 and 21(a) through 21(c) described further below). The membraneand shell are in substantially airtight engagement. When the membrane 34is pulled away from the shell 24, a vacuum is generated in the spacebetween the shell interior and the membrane, which can be accessedthrough outlet port 31 formed on the shell, to which a tube 32 isconnected to communicate the vacuum to a respective breastshield 17.

Power is provided either through ordinary house current via power cord38, or electrochemical battery 39, such as a pair of 6V, 1.2Ah lead-acidtype rechargeable batteries. Power cord 38 is provided on a wrap-aroundmount conveniently located for storage in a well in the bottom of thelower housing part 13. FIG. 7 shows wells 41 formed within the lowerhousing 13 through which the batteries 40 are inserted into receptaclesformed within the casing 10, having covers 42 for the wells. FIG. 7omits the detail of the wrap mount 40, for clarity.

The Single Switch Inversely Controlling Vacuum and Rate

An on-off switch or knob 45 (and see FIG. 9) is provided on the casing,which can be rotary or push-button to that end. It is nonetheless rotaryand push-button in this embodiment since it also acts to control theamount of vacuum being applied. As the knob 45 is rotated, a signal isgenerated which increases or decreases the level of vacuum (suctionforce) to be applied, depending on which way the knob is turned. In thisembodiment, as the suction force is increased, the cycle (rate) isdecreased. That is, the rate and force are inversely related. This isconsidered to have a beneficial effect. The knob is pushed in for on andoff.

The Function Indicator

Additionally visible from the exterior of the casing 10 is a LCD display48, a milk let-down button 49, and a program card slot 50 (the let-downsequence and programmable aspects will also be discussed in more detailbelow). Milk-let down button 49 is used to activate a pre-programmedsuction sequence (embodied in components to be hereinafter described)particularly adapted for let-down and stimulate the milk ejectionreflex. The slot 50 provides the interface access for programming cardsused with the breastpump of this invention.

The display 48 provides visual indications of various functions of thepump. This could include, for example, the type of sequence thenprogrammed, the level of suction force, the battery condition, and soforth.

The Diaphragm Protective Covers

In this embodiment, the two diaphragm pumps 30 are in a well formed inthe top of the casing 10. A cover 35 (also 35′ and 35″ (again, primednumbers being substantially similar to their un-primed counterparts)) isprovided which fits over the well and is generally flush with the upperhousing part 11. The outlets 31 extend through relieved areas in thecover 35, for example, for easy access in use.

It may be noted that the shells 24 are shown formed in the cover of theembodiment of FIG. 8. The FIG. 17 embodiment has the shells 24 mountedin a removable manner in the upper housing, as through a snap fit orinterference engagement, such as shown in the embodiment of FIGS. 20 and21(a) through 21(c), to allow easier access for cleaning or replacingthe membranes of the pumping mechanism, and for cleaning the shellsthemselves (which are provided with grips 33 to these ends).

In the FIG. 17 embodiment, diaphragm member or membrane 34, which may bemade of any suitably durable flexible and durable fluid-imperviousmaterial (to be airtight), such as silicone with a Shore A hardness inthe range of 30 to 70, is molded around its perimeter to a rigid plasticcollar 85. Collar 85 has a plurality of depending anchor posts 86 withoutboard flanges formed thereon, which engage with the inside lip of therespective well in the upper housing part 11 within which the collar 85is received to snap-fit the membrane 34 in place.

Prophylactic (protective) disposable/cleanable covers 36 areadditionally and advantageously provided, which form-fit over thediaphragms 34 and isolate them from air and other fluid from thebreastshields. The covers 36, which can be made of the same material asthe membranes but thinner, are likewise fluid-impervious.

Referring to FIGS. 20 and 21(a) through 21(c) in particular, each of thecovers 36 has an upturned cuff 87 which forms an annular well around theperimeter of the cover 36. A pair of circumferential beads 88 and 89,which are slightly offset vertically from each other, are formed alongthe bottom area of the annular well. Uppermost bead 88 engages in anannular rim channel 90 formed along the bottom outside of shell 24′, fora substantially airtight engagement between the protective cover 36 andthe shell.

An interior channel 93 is formed within the interior bottom of the cover36 by a bead 91 and shoulder 92, which each run circumferentially aroundthe cover. This interior channel 93 is received on a slightly protrudingedge or rim on the collar 85 of the membrane 34. An airtight fit is thusprovided between the protective cover 36 and the membrane 34, which alsoserves to releasably fix the shell 24 in place over the membrane 34, andcomplete the diaphragm pump 30.

Note also that a one-way valve 95 is provided in the membrane 34, whichcommunicates with the possible space that may form between the membrane34 and overlying cover 36. This valve permits any entrapped airtherebetween to be exhausted, such as if the first stroke on start-uphappens to be toward the shell 24, with the protective cover 36thereafter then following the movement of the diaphragm 34 to which itwill generally be in facial engagement.

The Programmable Aspects

One significant aspect of the present invention is the ability toprogram the breastpump with different types of suction sequences, orcycles as they are sometimes referred to herein. With reference to FIG.9, for instance, the breastpump utilizes a microprocessor-based systemindicated at 60 which is provided user input through a plurality of“chip” cards 61. Each chip card contains one or more predeterminedprograms recorded on an EEPROM. For example, each card could contain aspecific type of sequence along with a milk let-down sequence.

An EEPROM microcontroller of the type MB90562 may be used, for oneexample, or the Atmel 2-wire EEPROM chipcard microcontroller AT24C164for another. These provide about 16K of memory, which is consideredpresently sufficient.

The programs (some examples of which are described hereafter) arerecorded in a conventional manner, and would be provided to the motherready to use. The programmed chip card is inserted into the slot 50 inthe back of the casing 10, where it engages an interface to themicroprocessor. The particular program on the selected chip card 61 isthen communicated to the microprocessor 60. Microprocessor 60 isintegrated with the drive unit 25 to effect operation of the drive unitin accordance with the selected program, drawing upon either the ACpower source as converted via standard technology to DC (indicated at 68in FIG. 9), or from the battery source 39. The microprocessor 60 canalso control power management.

Suction force (e.g., the amount of negative pressure generated) willtypically also be adjustable by the user via operation of the rotarycontrol knob 45, as noted above. A pre-set range for the suction forcewill nonetheless ordinarily be provided in the program as an initialsetting, for adjustment by the user thereafter via the knob 45.

One embodiment contemplated provides a milk let-down sequence (milkejection reflex) that can be engaged without need of a chip card for thesame. The milk let-down sequence (described below) is pre-programmed inthe microprocessor 60, or may otherwise be wired into the circuitry in amanner to override the then existing operating program. When the motherdesires to engage this sequence, she presses the button 49, whichproduces and sends an electrical signal, as to the microprocessor 60.The let-down program is then effected.

It will be readily understood that a chip card 61 is but one way toprogram the microprocessor 60. Other input means could be used, such asmore dedicated buttons like button 49, each set to actuate a givensequence pre-programmed into the microprocessor 60. A numeric pad couldbe provided to input a code. The programs could be provided through anelectronic data link, such as a modem, or optically, or otherwise.

Data can also be recorded by the microprocessor for downloading ortransfer to the chip card. Data could also be directly recorded on thechip card. For instance, it is contemplated that the suckling action ofa particular child could be recorded and reduced to a sequence. Thatsequence could then be programmed into the pump, and the mother wouldthen have a suckling action from the pump very reminiscent of her ownchild.

Referring now to FIG. 10, the chip card 61 a with breastpump operationdata thereon is then read (downloaded) at a “card station” 75, shownhere as a card reader 76 linked to a computer 77. The computer 77 isused to transfer the data to one of a variety of available media, suchas CD, floppy disk, etc. for physical transfer to a research or datamonitoring facility, here indicated at 80. The data could also simply betransferred via modem through an Internet interface.

The New Expression Methods (Cycles)

It can thus be seen that a variety of different suction cycles orsequences can now be provided with the same breastpump equipment. Anexample of the kind of methods that such cycle could represent comprisesFIGS. 11 through 15.

FIG. 11, for instance, is what is referred to by Medela, Inc. as the“Standard Classic Program”. This is a method for operating a breastpumpthat has been developed which is considered to provide a general optimalsuction curve reminiscent of an infant's normal suckling, such asprovided by the 015 “CLASSIC” breastpump sold by Medela, Inc. Asindicated in the graph of FIG. 11, negative pressure is along the y-axis(in millimeters of mercury) and time (in seconds) along the x-axis. Inthis particular method, the cycles are fixed at about 47 per minute; theamount of suction is generally adjustable between about 100 to about 250mmHg.

FIG. 12 illustrates what can be termed as a new “Sore Nipple Program”method. In comparison to FIG. 11, it will be seen that the lower end ofthe vacuum range is reduced to about 20 mmHg, and the overall suctioncycle is extended in duration, i.e., from a low of about 25 cycles/min.to about 40. For a lower vacuum applied in this program, there is anincrease in the number of cycles. In general, however, there is a slowerand gentler suction compared with the “CLASSIC” program of FIG. 11.

FIG. 13 shows a new method for operating a breastpump which isconsidered to yield an increase in milk output. This is a program thatmight be applied between regular pump sessions several times a day. Inthis method, the breastpump is operated at a rapid cyclical rate on theorder of about 120 cycles/min., preferably with a pause after a periodof vacuum application; here, 10 seconds of vacuum, then a 2 secondpause. The negative pressure is in the range of about 50 to about 150mmHg. Note the detail in the inset of FIG. 13 showing the rapidity andsteep slopes of the vacuum application.

What has been termed a new “Superior Program” for operating a breastpumpis illustrated in FIG. 14. A vacuum range of about 100 to about 250 mmHghas been chosen, with cycles ranging from about 47 to about 78 perminute. The cycle rate and the vacuum are tied, such that as, forinstance, the cycles decrease, the amount of vacuum increases, i.e.,there is an inverse relationship. It will be noted that this programdiffers from the “CLASSIC” program above in part through a sequence thatinitially reaches a peak negative pressure, then smoothly starts apressure increase (less negative) along a similar (although opposite)slope to that of the negative pressure build-up, but then slows thepressure increase briefly, before continuing on essentially the initialslope for the negative pressure release. A milk let-down sequence isalso incorporated in this “Superior Program,” and utilizes a vacuumrange of about 50 to about 150 mmHg, with cycles ranging between about80 to about 160 per minute.

Thus, while the invention has been described herein with relation tocertain embodiments and applications, those with skill in this art willrecognize changes, modifications, alterations and the like which stillcome within the spirit of the inventive concept, and such are intendedto be included within the scope of the invention as expressed in thefollowing claims.

What is claimed is:
 1. In a diaphragm pump protection device for abreastpump, where the breastpump has a pumping device including a shelland a member moveable relative to the shell, the improvement comprising:a removably mounted cover, said removably mounted cover being receivedbetween the shell and the member moveable relative to the shell of thebreastpump and mounted upon and traveling with the moveable member, saidremovably mounted cover isolating the moveable member relative to theshell from any fluid.
 2. The diaphragm pump protection device of claim 1wherein said diaphragm pump protection device is flexible anddisposable.
 3. A pump for a breastpump comprising: a chamber defined bya shell and a member movable relative to said shell; a mechanismconnected to said movable member which moves said movable member toexpand and contract a volume defined within said chamber; a port in saidshell through which fluid moves in response to expansion and contractionof said volume; and a removably mounted cover between said shell andsaid movable member isolating said movable member from fluid, said coverbeing removable for at least one of cleaning and disposal.
 4. The pumpof claim 3 wherein said cover is flexible.
 5. The pump of claim 3wherein said movable member has a circumferential rim, said cover beingreceived over said rim, and said shell has an internal opening definedtherein sized to encompass said rim with said cover mounted on said rimin a substantially airtight fit, said cover thereby forming a gasketbetween said rim and shell.
 6. The pump of claim 3 further including aone-way, valve extending through said movable member, said valveallowing exhaustion of air between said movable member and said covermounted thereon.
 7. The pump of claim 6 wherein said pump is a diaphragmpump, said shell having a generally hemispherical interior shape, saidmovable member being a flexible membrane.
 8. The pump of claim 3 whereinsaid pump is a diaphragm pump, said shell having a generallyhemispherical interior shape, said movable member being a flexiblemembrane.
 9. A diaphragm pump for a breastpump, comprising: a shellhaving a generally hemispherical interior shape; a flexible membranemovable within said hemispherical shape to expand and contract a volumecreated in a chamber defined between said membrane and shell; amechanism connected to said membrane which moves said membrane to expandand contract said volume; a port in said shell through which air movesin response to expansion and contraction of said volume; a removablymounted flexible cover between said shell and said membrane whichisolates said membrane from fluid, said cover being removable for atleast one of cleaning and disposal, said flexible membrane having acircumferential rim, said cover being received over said rim, and saidshell having an internal opening defined therein sized to encompass saidrim with said cover mounted on said rim in a substantially airtight fit,said cover thereby forming a gasket between said rim and shell.
 10. Thepump of claim 9 further including a one-way valve extending through saidmovable member, said valve allowing exhaustion of air between saidmovable member and said cover mounted thereon.